RecruitingPhase 1/2

A Study of BGB-11417 in Participants With Myeloid Malignancies

United States260 participantsStarted 2021-05-24

Plain-language summary

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
✓. Eastern Cooperative Oncology Group performance status of 0 to 2.
✓. Adequate organ function defined as:
✓. Life expectancy of \> 12 weeks.
✓. Ability to comply with the requirements of the study.

Exclusion criteria

✕. A diagnosis of acute promyelocytic leukemia.
✕. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)
✕. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
✕. Prior therapy with a B-cell lymphoma-2 inhibitor
✕. Known central nervous system involvement by leukemia.

What they're measuring

Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)

Timeframe: Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)

Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Approximately 24 months

Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate

Timeframe: Approximately 24 months

Part 3 MDS Cohort: Modified Overall Response (mOR) Rate

Timeframe: Approximately 24 months

Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable timepoint (t) (AUC0-t) Of BGB-11417 When Administered Alone and when Co-administered With Posaconazole

Timeframe: Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)

Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole

Timeframe: Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)

Trial details

NCT IDNCT04771130

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02-08

Contact for this trial

BeiGene

1.877.828.5568 clinicaltrials@beigene.com

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
✓. Eastern Cooperative Oncology Group performance status of 0 to 2.
✓. Adequate organ function defined as:
✓. Life expectancy of \> 12 weeks.
✓. Ability to comply with the requirements of the study.

Exclusion criteria

✕. A diagnosis of acute promyelocytic leukemia.
✕. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)
✕. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
✕. Prior therapy with a B-cell lymphoma-2 inhibitor
✕. Known central nervous system involvement by leukemia.

What they're measuring

Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)

Timeframe: Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)

Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Approximately 24 months

Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate

Timeframe: Approximately 24 months

Part 3 MDS Cohort: Modified Overall Response (mOR) Rate

Timeframe: Approximately 24 months

Timeframe: Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)

Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole

Timeframe: Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)